AROCELL VITA20 POWER by FICC Co., Ltd. / Cosmax, Inc.

AROCELL VITA20 POWER by

Drug Labeling and Warnings

AROCELL VITA20 POWER by is a Otc medication manufactured, distributed, or labeled by FICC Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AROCELL VITA20 POWER- dimethicone stick 
FICC Co., Ltd.

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ACTIVE INGREDIENT

Dimethicone 9.0%

INACTIVE INGREDIENTS

Ascorbic Acid (20%), Cetyl Ethylhexanoate, Hydrogenated Vegetable Oil, Triethylhexanoin, Paraffin, Phenyl Trimethicone, Polyethylene, Diisostearyl Malate, Olea Europaea (Olive) Fruit Oil, Polymethylsilsesquioxane, Silica, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Glycyrrhiza Glabra (Licorice) Root Extract, Silica Silylate, Sorbitan Isostearate, Silica Dimethyl Silylate, VP/Hexadecene Copolymer, Cera Microcristallina (EU), Caprylyl Glycol, Fragrance (Parfum)

PURPOSE

Skin protectant

WARNINGS

For external use only
Consult a specialist if there are abnormal symptoms or side effects such as redness, swelling or itchiness due to direct sunlight during or after use.
Avoid using on wounded areas.
Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

■ Helps protect your skin.
■ Helps brighten skin tone.

Directions

■ Apply evenly onto areas with uneven pigmentation.
■ Replace the cover after use.

Other Information

■ Keep away from direct sunlight.
■ The formulation may soften at a temperature of 113°f or higher, but the content is still safe for use.
■ Recommend using at night prior to sleep.
■ Ascorbic acid (20%) may cause irritation for those with sensitive skin. To prevent possible irritation, apply as the final step of skin care routine.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AROCELL VITA20 POWER 
dimethicone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81647-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	0.9 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)
Cetyl Ethylhexanoate (UNII: 134647WMX4)
Triethylhexanoin (UNII: 7K3W1BIU6K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81647-100-02	1 in 1 CARTON	03/01/2021	10/01/2022
1	NDC: 81647-100-01	10 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	03/01/2021	10/01/2022

Labeler - FICC Co., Ltd. (695721074)

Registrant - FICC Co., Ltd. (695721074)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(81647-100)

Revised: 12/2023

Document Id: 32de447b-98a1-4a73-9618-b602e0ebdd15

34390-5

Set id: 0948df9e-aaa2-4baa-a2a0-c4ed87fb827a

Version: 4

Effective Time: 20231205